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The National Pharmaceutical Pricing Authority (NPPA) has extended the ceiling price fixation for orthopaedic knee implants used in knee replacement systems another year, that is, till November 2026.
In a notification dated September 15, the drug price regulator said the fixed price ceiling shall remain in force for orthopaedic knee implants for a further period of up to one year, that is, till November 15, 2025, or further order, whichever comes earlier.
Why did the NPPA extend the price ceiling?
The decision, taken at the 139th meeting of the authority on November 14, comes at a time when several manufacturers and industry associations have been submitting representations asking the NPPA to remove the ceiling.
Some representations had also sought a 10 per cent price hike under Drugs Prices Control Order (DPCO) rules, citing various reasons such as fluctuations in foreign exchange rates, increased manpower and freight costs, rises in the Wholesale Price Index (WPI) and supply chain problems.
They have also been pressing the authority to create a separate category for innovative knee implants that could be kept out of price control to encourage innovations and research and development.
What does the extended ceiling mean for affordability?
While the NPPA had previously indicated that these representations are under consideration, the extension of price capping may have been done to ensure affordability.
Currently, the cost of the primary knee replacement system (titanium alloy coated) has been capped at Rs 51,563. The cost of the revision knee replacement system has been capped at Rs 83,547.
In previous orders, the NPPA has noted unjustified, unreasonable and irrationally high trade margins on orthopaedic knee implants, leading to exorbitant prices that increased out-of-pocket expenses for patients.
How significant is India’s knee implant market?
India is a major consumer of knee implants, with the country recording more than 250,000 knee replacement surgeries every year.
The NPPA had first notified the ceiling price of orthopaedic knee implants in 2017, cutting costs for patients by up to 70 per cent by invoking extraordinary powers under Paragraph 19 of the Drugs Prices Control Order (DPCO) 2013, for a period of one year.
The time limit for this price ceiling has been extended every year since then, with the previous extension for two months being announced on September 15.
